Budding Biotech In New Haven Receives $15 Million Loan

A budding pharmaceutical company receives $15 million to develop chronic-itch drug.

A budding pharmaceutical company in New Haven received a $15 million loan that will allow it to finish clinical trials on a treatment for chronic itching associated with kidney dialysis and, separately, a rare skin condition marked by hard, crusty bumps.

Trevi Therapeutics Inc. of New Haven was formed in 2012 and is in late-stage development of its drug, Nalbuphine ER. In total the company has raised $55 million to develop its drug, including the $15 million loan announced Thursday from Solar Capital Ltd.

The drug is used to treat uremic pruritus, which is also called renal pruritis, and is caused by chronic kidney failure, resulting in nonstop itching. The condition occurs in about 40 percent to 45 percent of people who undergo kidney dialysis, which is about 180,000 to 202,500 patients in the U.S., said Jennifer Good, president and CEO of Trevi Therapeutics.

The drug also can be used to treat prurigo nodularis, a condition that results in hard, crusty lumps on the skin that are sore and itchy. Prurigo nodularis can be triggered by nervous and mental conditions, reduced function of the liver or kidneys, and skin diseases such as eczema, bullous pemphigoid and dermatitis herpetiformis.

The drug is an oral tablet that addresses the root cause of an itch. For people undergoing kidney dialysis, the body senses something foreign about the blood after dialysis and the body reacts with an itchy feeling, Good said.

Trevi Therapeutics is an example of a common theme in pharmaceutical development, which is the development of new treatments for severe, specific diseases.

The company has about 10 employees and another 7 or 8 full-time consultants, which could grow this year.

The $15 million loan allows the company to get through two pivotal clinical trials involving 360 uremic-pruritus patients and 60 patients with prurigo nodularis. If the results of the study are positive, the company will likely be able to double its staff, Good said.

The trials are expected to finish this summer. The medications could become available, after federal regulatory approval, by late 2016. If the drug requires another clinical trial, the drug might not be available until 2017.

Good added that New Haven is an attractive place to develop because of its proximity to Yale, other biotechnology companies in the area and Metro-North Railroad.